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FDA Chief Counsel Defends COVID-19 EUAs, Praises ‘Moral Strength’ Of Commissioner Hahn

 
• By Brenda Sandburg

Stacy Cline Amin says authorizing or licensing a COVID-19 vaccine is ‘perhaps the most consequential action the agency will ever take.’ Speaking at FDLI conference, she notes that standards for vaccine EUA will be higher than what has been required for therapeutics.

FDA chief counsel Stacy Cline Amin
FDA Chief Counsel Stacy Cline Amin

US Food and Drug Administration Chief Counsel Stacy Cline Amin tackled the criticism that has engulfed the agency over its issuance of emergency use authorizations (EUAs) for COVID-19 therapeutics and emphasized the strict standards that must be met to obtain an EUA for a vaccine.

In a 6 October keynote address at the Food and Drug Law Institute’s virtual annual conference, Amin said it seems like the agency was “criticized from every direction” over the EUAs for hydroxychloroquine and convalescent plasma

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